NeuroVive Discontinues Development of CicloMulsion for Acute Kidney Injury

NeuroVive Pharmaceutical AB (STO:NVP)(OTCQX: NEVPF), the mitochondrial medicine company, today announced results from the exploratory clinical phase II study CiPRICS. The results clearly show that patients treated with CicloMulsion prior to open heart surgery experience no benefit compared to placebo in the prevention of acute kidney injury (AKI). As a result, NeuroVive will discontinue the development of CicloMulsion for AKI.
The exploratory CiPRICS study, aimed at preventing AKI in patients
undergoing open heart surgery, did not reach the primary objective. In
contrast, patients in the active dose group showed a transient, but
statistically significant increase in the biomarkers P-cystatin C and
P-creatinine compared to placebo. No unexpected tolerability issues were
observed and the overall frequencies of serious adverse events were
comparable to those observed in the placebo group.
“Since the overall goal for this study was to offer a preventive
treatment to patients at risk of developing AKI, the outcome of the
study was a disappointment. However, the CiPRICS study has given us very
important information about ciclosporin treatment in this patient
population. Also, we have appreciated the fruitful and close
collaboration with the NeuroVive clinical team”, says
Sponsor-Investigator, Associate Professor Henrik Bjursten M.D. Ph.D.,
Department of Cardiothoracic Surgery, Anesthesia and Intensive Care at
Skåne University Hospital in Lund, Sweden.
Given the current findings, NeuroVive has decided to discontinue the
development of CicloMulsion in AKI and redirect resources to its other
development assets. NeuroVive continues to progress its opportunities
within mitochondrial medicine, an area with high unmet medical needs.
The ciclosporin (NeuroSTAT) development program in traumatic brain
injury (TBI) will proceed. NeuroVive will continue development of its
unique non-Ciclosporin based cyclophilin inhibitors for organ protection
and other unrelated indications. In addition to these high-value
possibilities, NeuroVive has several other promising early projects with
different, novel modes of action within the area of mitochondrial
medicine.
“The CiPRICS study has been excellently conducted by the team, led by
Associate Professor Bjursten at Skåne University Hospital, with clear
results. Moreover, it has verified the effectiveness of the network
partnership model for NeuroVive’s early clinical development”, says
NeuroVive’s CEO Erik Kinnman. “We will continue to develop and build our
portfolio, and I see several potential upcoming milestone events in our
strong and diversified mitochondrial medicine portfolio.”
A web cast for presentation of the study results will be held at 3:00
p.m. today. To listen to the presentation please visit https://wonderland.videosync.fi/2016-10-13-neurovive-press-conference.
To call-in please use one of the following numbers: Sweden: +46856642690
UK: +442030089815 US: +18558315946.
Dr. Bjursten will this afternoon give an oral presentation with the
title Ciclosporin to Protect Renal Function In Cardiac Surgery
(CiPRICS). A Double Blind, Randomised, Placebo Controlled, Proof of
Concept Study at the Swedish Thorax meeting in Malmö. For further
information about the program, please visit the conference web site:
https://www.malmokongressbyra.se/svenska_thoraxmotet/program.
About CiPRICS
The CiPRICS study (Ciclosporin to Protect Renal Function In Cardiac
Surgery) was a double-blind, randomized and placebo-controlled
exploratory phase II study that investigated NeuroVive’s candidate drug
CicloMulsion in the prevention of acute kidney injury (AKI) in open
heart surgery. The primary endpoint was relative changes in P-cystatin C
between the treatment groups three days after surgery. Secondary
endpoints included evaluation of P-creatinine and other biomarkers of
kidney, heart and brain injury. The study encompassed 155 patients who
were treated with CicloMulsion or placebo prior to coronary artery
bypass surgery (CABG) at the Department of Cardiothoracic Surgery,
Anesthesia and Intensive Care at Skåne University Hospital in Lund,
Sweden. The study was investigator-initiated and performed by Skåne
University Hospital with support from NeuroVive. More information about
the study is published in the public database www.ClinicalTrials.gov.
About NeuroVive
NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF), is a
pioneer in mitochondrial medicine and a company committed to the
discovery and development of highly targeted candidates that preserve
mitochondrial integrity and function in areas of significant therapeutic
need. NeuroVive’s business approach is driven by value-adding
partnerships with mitochondrial research institutions and commercial
partners across the globe. NeuroVive is listed on Nasdaq Stockholm,
Sweden, Small Cap, under the ticker symbol NVP. The share is also traded
on the OTC Markets Group Inc. market in the US. NeuroVive Pharmaceutical
(OTC: NEVPF) trades on the OTCQX Best Market.
NeuroVive Pharmaceutical AB (publ) Medicon Village, SE-223 81 Lund,
Sweden Tel: +46 (0)46 275 62 20 (switchboard)
www.neurovive.com
This information is information that NeuroVive Pharmaceutical AB (publ)
is obliged to make public pursuant to the EU Market Abuse Regulation.
The information was submitted for publication, through the agency of the
contact person set out above, at 08:30 a.m. CEST on October 13, 2016.
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